The Central Drugs Standard Control Organisation (CDSCO) has prohibited the use of anti-cold fixed drug combination in children below four years of age. Drugs Controller General of India (DCGI) Rajeev Raghuvanshi has asked the drug regulators of all states and Union territories to instruct the manufacturers of fixed drug combination (FDC) of Chlorpheniramine Maleate IP 2mg + Phenylephrine HCL IP 5mg drop/ml to insert warning that FDC should not be used in children below 4 years of age on label and package insert/promotional literature of the drug.
The banned medicine is a combination of decongestants, antihistamines, and pain relievers, commonly used to treat symptoms like runny nose, cough, and fever. TheHealthSite.com
The Central Drugs Standard Control Organisation (CDSCO), along with state drug inspectors, have been doing these inspections as part of a massive nationwide crackdown on spurious and substandard medicines. At present Phase IV of risk based inspections (RBI) is ongoing.